The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Comfit Blue Powder Free Examination Gloves.
| Device ID | K943563 |
| 510k Number | K943563 |
| Device Name: | COMFIT BLUE POWDER FREE EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | WEMBLEY RUBBER PRODUCTS (M) SDN BHD KAWASAN PERUSAHAAN BANDAR BARU LOT 1, JALAN 3 Sepang Selangor, MY 43900 |
| Contact | Ong Ghee Chee |
| Correspondent | Ong Ghee Chee WEMBLEY RUBBER PRODUCTS (M) SDN BHD KAWASAN PERUSAHAAN BANDAR BARU LOT 1, JALAN 3 Sepang Selangor, MY 43900 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-22 |
| Decision Date | 1995-03-07 |